- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT00655850
Lower Dose Chemotherapy Given More Frequent With Avastin to Treat Advanced Non-Squamous Non-Small Cell Lung Cancer
Pilot Phase II Study of Metronomic Chemotherapy in Combination With Avastin in Patients With Advanced Non-Squamous Non-Small Cell Lung Cancer
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
This is a non-randomized, open-label, pilot Phase II study of metronomic chemotherapy plus Avastin in chemo naïve subjects with advanced non-squamous, non-small cell carcinoma of the lung. The primary endpoint of this study is to assess the overall progression-free survival.
Subjects will be treated with metronomic chemotherapy with paclitaxel and gemcitabine weekly for 3 out of 4 weeks, and Avastin will be administered every 2 weeks. Treatment with metronomic chemotherapy will be expressed as a 4-week cycle. Tumor response to treatment will be evaluated every 8 weeks.
Treatment with metronomic chemotherapy and Avastin will continue for a total of 6 cycles unless there is evidence of disease progression, intolerable toxicity, or withdrawal of consent. Maintenance therapy with Avastin will then continue until disease progression, intolerable toxicity or withdrawal of consent.
Potential biologic parameters to monitor anti-tumor activity of metronomic chemotherapy will be evaluated in 10 subjects. These biomarkers include: sequential determination of blood levels of VEGF, VEGFR2, thrombospondin-1, E-selectin, ICAM-1, and circulating endothelial cells and endothelial precursor cells.
Studietyp
Inskrivning (Faktisk)
Fas
- Fas 2
Kontakter och platser
Studieorter
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Alabama
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Birmingham, Alabama, Förenta staterna, 35294 - 0104
- University of Alabama at Birmingham
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Neutrophil Count greater than or equal to 1500/μL
- Platelet Count greater than or equal to 100,000/μL
- Hemoglobin greater than or equal to 9.0g/dL
- Total Bilirubin ≤ 1.5mg/dL
- Transaminases ≤ 2.5 x ULN
- Serum Creatinine ≤ 1.5 x ULN
- Proteinuria: Urine protein: creatinine (UPC) ratio < 1.0 at screening OR Urine dipstick for proteinuria < 2+ (patients discovered to have ≥2+ proteinuria on dipstick urinalysis at baseline should undergo a 24 hour urine collection and must demonstrate ≤ 1g of protein in 24 hours to be eligible).
INR ≤ 1.5 and a PTT no greater than the ULN
- Subjects must be 19 years or older.
- Subjects with a history of hypertension must be well-controlled (< 150/100) on a stable regimen of anti-hypertensive therapy.
- Subjects must not have serious non-healing wound ulcer, or bone fracture, or major surgical procedure within 28 days prior to starting treatment.
- Subjects must not have radiation therapy within 3 weeks prior to initiation of treatment.
- Female subjects must be postmenopausal, surgically sterile, or using effective contraception. All females of childbearing potential must have a negative serum pregnancy test within 7 days prior to the initiation of treatment.
- Informed consent must be obtained in writing prior to the initiation of treatment.
Exclusion Criteria
- Inability to comply with study and/or follow-up procedures
- Life expectancy of less than 12 weeks
- Current, recent (within 4 weeks of the first infusion of this study), or planned participation in an experimental drug study other than a Genentech-sponsored Avastin cancer study
- Active malignancy, other than superficial basal cell and superficial squamous (skin) cell, or carcinoma in situ of the cervix within last five years
Avastin-Specific Exclusions
- Inadequately controlled hypertension (defined as systolic blood pressure > 150 mmHg and/or diastolic blood pressure > 100 mmHg)
- Prior history of hypertensive crisis or hypertensive encephalopathy
- New York Heart Association (NYHA) Grade II or greater congestive heart failure
- History of myocardial infarction or unstable angina within 6 months prior to Day 1
- History of stroke or transient ischemic attack within 6 months prior to Day 1
- Known CNS disease, except for treated brain metastasis Treated brain metastases are defined as having no evidence of progression or hemorrhage after treatment and no ongoing requirement for dexamethasone, as ascertained by clinical examination and brain imaging (MRI or CT) during the screening period. Anticonvulsants (stable dose) are allowed. Treatment for brain metastases may include whole brain radiotherapy (WBRT), radiosurgery (RS; Gamma Knife, LINAC, or equivalent) or a combination as deemed appropriate by the treating physician. Patients with CNS metastases treated by neurosurgical resection or brain biopsy performed within 3 months prior to Day 1 will be excluded
- Significant vascular disease (e.g., aortic aneurysm, requiring surgical repair or recent peripheral arterial thrombosis) within 6 months prior to Day 1
- History of hemoptysis (greater than or equal to 1/2 teaspoon of bright red blood per episode) within 1 month prior to Day 1
- Evidence of bleeding diathesis or significant coagulopathy (in the absence of therapeutic anticoagulation)
- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 1 or anticipation of need for major surgical procedure during the course of the study
- Core biopsy or other minor surgical procedure, excluding placement of a vascular access device, within 7 days prior to Day 1
- History of abdominal fistula or gastrointestinal perforation within 6 months prior to Day 1
- Serious, non-healing wound, active ulcer, or untreated bone fracture
- Proteinuria as demonstrated by a UPC ratio greater than or equal to 1.0 at screening
- Known hypersensitivity Criteria:
- Pathological-proven NSCLC except squamous cell carcinoma as the predominant histology.
- Advanced NSCLC: Stage IIIB with pleural effusion or Stage IV or recurrent disease.
- Measurable or non-measurable disease as defined by solid tumor response criteria (RECIST)
- ECOG Performance Status 0 to 1.
- No prior systemic chemotherapy or biologic therapy.
- Required laboratories (obtained ≤ 1 week prior to the initiation of treatment)
- Absolutely any component of Avastin
- Pregnancy (positive pregnancy test) or lactation. Use of effective means of contraception (men and women) in patients of child-bearing potential
- Intrathoracic lung carcinoma of squamous cell histology Mixed tumors will be categorized by the predominant cell type unless small cell elements are present, in which case the patient is ineligible; sputum cytology alone is acceptable. Patients with extrathoracic-only squamous cell NSCLC are eligible. Patients with only peripheral lung lesions (of any NSCLC histology) will also be eligible (a peripheral lesion is defined as a lesion in which the epicenter of the tumor is less than or equal to 2 cm from the costal or diaphragmatic pleura in a three-dimensional orientation based on each lobe of the lung and is greater than 2 cm from the trachea, main, and lobar bronchi).
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
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Experimentell: Paclitaxel and Gemcitabine + Avastin
Patients will be treated with metronomic chemotherapy with paclitaxel and gemcitabine weekly for 3 out of 4 weeks which constitutes one cycle (4 weeks).
Avastin will be administered every 2 weeks.
Treatment with metronomic chemotherapy and Avastin will continue for a total of 6 cycles unless there is evidence of disease progression, intolerable toxicity, or withdrawal of consent.
Maintenance therapy with Avastin will continue until disease progression, intolerable toxicity, or withdrawal of consent.
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Paclitaxel Dose Levels:
Andra namn:
Premedication
Gemcitabine Dose Levels:
Andra namn:
Andra namn:
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Progression-Free Survival (PFS)
Tidsram: Baseline to 24 months
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Progression Free Survival is defined as the number of days from the day the subject started treatment to the day the subject experiences disease progression in accordance with the Response Evaluation Criteria Solid Tumors (RECIST v1.0).
The RECIST criteria indicates progression as a 20% increase in the total tumor measurement over nadir value or the appearance of new lesions.
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Baseline to 24 months
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Number of Participants With Adverse Events
Tidsram: Baseline through duration of treatment an average of 1 year
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All adverse events will be recorded as to the grade and relationship to the study drug in accordance with the Common Terminology Criteria for Adverse Events (CTCAE v 3.0)
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Baseline through duration of treatment an average of 1 year
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Overall Survival (OS)
Tidsram: Baseline up to 84 months
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Overall Survival is defined as the number of days from the day the subject started treatment to the day the subject experiences death or lost to follow up.
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Baseline up to 84 months
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Objective Response Rate
Tidsram: Baseline up to 12 months
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The percentage of patients who achieve a complete response and partial response according to RECIST criteria (v1.0).
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Baseline up to 12 months
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Samarbetspartners och utredare
Samarbetspartners
Utredare
- Huvudutredare: Francisco Robert, M.D., University of Alabama at Birmingham
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Luftvägssjukdomar
- Neoplasmer
- Lungsjukdomar
- Neoplasmer efter plats
- Neoplasmer i andningsvägarna
- Thoracic neoplasmer
- Karcinom, bronkogent
- Bronkiella neoplasmer
- Lungneoplasmer
- Karcinom, icke-småcellig lunga
- Läkemedels fysiologiska effekter
- Molekylära mekanismer för farmakologisk verkan
- Anti-infektionsmedel
- Antivirala medel
- Enzyminhibitorer
- Antimetaboliter, antineoplastiska
- Antimetaboliter
- Antineoplastiska medel
- Immunsuppressiva medel
- Immunologiska faktorer
- Tubulin modulatorer
- Antimitotiska medel
- Mitosmodulatorer
- Antineoplastiska medel, fytogena
- Antineoplastiska medel, immunologiska
- Angiogeneshämmare
- Angiogenesmodulerande medel
- Tillväxtämnen
- Tillväxthämmare
- Gemcitabin
- Paklitaxel
- Bevacizumab
Andra studie-ID-nummer
- F070727010
- UAB 0709
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
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